The principle of classification of medical devices in each country is based on the overall risk level, with Class 1 being the lowest and Class 2.3 being the highest.
China's "Medical Device Classification Rules (Bureau Decree No. 15)" stipulates:
Article 4: To determine the classification of medical devices shall be based on the structural characteristics of the medical device, the form of use of the medical device and medical devices used in the three aspects of the situation of a comprehensive judgment.
The specific determination of medical device classification can be based on the "Medical Device Classification Determination Table" (see annex).